PRA has two fully equipped and harmonized bioanalytical laboratories; one based in Europe (Assen, The Netherlands) and the other based in the United States (Lenexa, Kansas) . Both the US and EU laboratories are situated close to our clinics to facilitate studies producing time-sensitive samples. The Lenexa facility first came on-line in October 2010, and is fully equipped with state-of-the-art bioanalytical instrumentation to provide expertise and security for your clinical samples. The Assen facility has been active since the mid-1980s to support our Phase I Clinics in Zuidlaren and Groningen and provides a benchmark for the quality of our laboratory services.
Our bioanalytical laboratories in Assen and Lenexa provide clients with:
- Analytical capabilities for pre-clinical and Phase I-IV trials
- Consultation services
- Design and writing services for bioanalytical protocols and method feasibility studies
- Technology transfer expertise
- Development, implementation and validation of assay methods for small and large molecules
- Bioanalysis of samples from clinical and pre-clinical studies according to FDA guidelines and GLP
- Bioanalytical reports prepared to standard templates or as per client specification
- Reports prepared in eCTD format for electronic data transfer
PRA Bioanalytical Services
Across our facilities in Europe and North America we offer a comprehensive range of research and analytical methodology. Standard operating procedures (SOPs) for bioanalytical laboratories in Europe and the United States are harmonized to ensure consistent outcomes.
- State-of-the-art Mass Spectrometry laboratories offering comprehensive high-throughput LC-MS/MS services across Europe and the United States
- Ligand Binding Assay laboratory offering a full range of modern immunoassay and biomarker studies
- Flow cytometry cell studies to provide cell data supporting drug efficacy in Phase I studies
- Radioisotope laboratory with validated methods to analyze 14C, 3H and 125I levels across a range of biological matrices
- Biohazard Laboratory at Assen, rated to Bio-Safety Level II (ML-II) and able to handle pathogens such as Hepatitis B/C, HIV and Mycobacterium tuberculosis. Lenexa laboratory is able to assay HIV and Hepatitis B samples.
To search for assay methods currently available at PRA, click here